Working Papers and Chapters and Reporter Articles

The economics of stratified medicine depend critically on setting the cut-off score of the companion diagnostic (CDx). This action integrates scientific, clinical, ethical and commercial considerations, and simultaneously determines the value of the stratified medicine to developers, providers, payers and patient. Setting a high cut-off ensures a larger response by excluding more non-responders but also denies treatment to patients who would respond. This creates ethical and clinical concerns, and limits market size. Setting a low cut-off includes more patients who can benefit but includes more non-responders with commensurate costs, side effects and lost time. CDx’s capture little value under current reimbursement and exclusivity protections. Combined with low CDx investment incenti...

Much has been written about the seemingly less formal, more agile biotechnology industry and its extensive interactions with academia and startups, as well as its distinct scientific, manufacturing and regulatory profile. Employing a data base encompassing all 96 biologics and 212 small molecules newly launched in the U.S. between 1998Q1 and 2008Q4, we compare their downstream clinical and commercial characteristics -- therapeutic class concentration, launch delays following approval, Orphan Drug and priority review status, supplemental indications, black box warning and safety record, and pricing and revenue growth during the product life cycle. We conclude that the market dynamics of biologics differ substantially from those of small molecules, although therapeutic class composition pl...